Berkeley, California-based Eko Devices has received FDA clearance for Duo, a smart heart monitor that is a combination of a digital stethoscope and portable electrocardiogram.
Duo is intended as a prescription-only screening tool as part of an at-home monitoring plan, and it works with a companion app for remote monitoring or diagnosis. The idea is to keep continuous tabs on patients at risk for heart failure rather than relying on in-office visits that are inadequate in monitoring such complex medical conditions.
"Eko Duo’s consumer-friendly design can help transform how clinicians monitor heart health in-person or virtually," Dr. John Chorba, a cardiologist and assistant professor at University of California San Francisco said in a statement provided by Eko. "We need powerful tools that heart failure patients can use to improve self-care and communicate troubling findings with an expert."
This is Eko’s second FDA-cleared smart device. The company, founded in 2013 by three UC Berkeley graduates, received FDA clearance in 2015 for its smart stethoscope called Core, and the device is now in use at over 700 hospitals and health systems worldwide. Eko also developed a proprietary telemedicine software platform to enable live streaming of clinical quality cardiopulmonary sound and ECG on any device.
The company – which previously raised around $2.8 million and lists the Stanford’s StartX Fund, DreamIT Ventures and the cofounders of Shazam as investors – is also building machine-learning algorithms to work with Duo in order to automatically alert patients and their care teams of decline in cardiac function. Altogether, Eko’s platform aims to usher in a new way to deliver mobile, non-invasive cardiac care.
"The ability to capture digital heart sounds and an ECG expands our portfolio of mechanisms to remotely monitor the heart, and brings diagnosis and opportunities for early intervention even further upstream,” stated Dr. Ami Bhatt, who is director of outpatient cardiology at Massachusetts General Hospital. “Robust toolkits for caring for patients in the community will hopefully lead to more appropriate healthcare utilization through continuous rather than episodic outpatient care."
